National Cancer Institute (NCI)
National Eye Institute (NEI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Library of Medicine (NLM)
National Center for Complementary and Integrative Health (NCCIH)

The purpose of this Funding Opportunity Announcement (FOA)
is to support high quality and impactful conferences/scientific meetings that
are convened by data science related organizations whose missions focus on
biomedical data science. This FOA, which uses the NIH conference cooperative
agreement program (U13), is part of the NIH-wide initiative, Big Data to
Knowledge (BD2K). Data science related organizations have a critical role in
advancing biomedical data science but often depend on meetings to carry out
their work. This FOA will support high quality conferences or meetings that
are relevant to the biomedical data science needs of the participating
Institutes and Centers of the National Institutes of Health. For the purpose
of this FOA, a conference is defined as a gathering, such as in the form of a
symposium, seminar, scientific meeting, workshop, or any other organized and
formal meeting where persons assemble to coordinate, exchange, and
disseminate information, or to explore or clarify a defined subject, problem,
or area of knowledge. Applicants representing data science related
organizations may request support for one or a series of meetings over
multiple years that address areas of data science aligned with the goals of
the NIH BD2K program.

Key Dates

Posted Date

October 7, 2016

Open Date (Earliest Submission Date)

November 15, 2016

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

New Date December 15, 2016; by 5:00 PM local time
of applicant organization. All types of
applications allowed for this funding opportunity announcement are due on
these dates.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

New Date February/March 2017

Advisory Council Review

New Date May 2017

Earliest Start Date

New Date July 2017

Expiration Date

New Date December 16, 2016 per issuance of NOT-RM-17-011. (Original Expiration Date: December 1, 2018 )

Due Dates for E.O. 12372

Not Applicable

Required
Application Instructions

It is critical that applicants follow the instructions in
the Research Instructions for the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both
in the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

This FOA, which uses the NIH conference cooperative
agreement program (U13), is part of the NIH-wide initiative, Big Data to
Knowledge (BD2K). Data science related organizations have a critical role in advancing
biomedical data science but often depend on meetings to carry out the work that
will foster greater cooperation of efforts with the NIH. Therefore, the purpose
of this Funding Opportunity Announcement (FOA) is to support high quality and
impactful conferences/meetings that are convened by data science related
organizations whose missions focus on biomedical data science.

For this announcement, a conference is defined as a
gathering, such as in the form of a symposium, seminar, scientific meeting,
workshop, or any other organized and formal meeting where persons assemble to
coordinate, exchange, and disseminate information, or to explore or clarify a
defined subject, problem, or area of knowledge.

Applicants representing data science related organizations
may request support for one or a series of meetings over multiple years that address
areas of data science aligned with the goals of the NIH BD2K program.

Background

Biomedical research is rapidly becoming more data-intensive
as investigators are generating and using increasingly large, complex,
multidimensional, and diverse datasets. This era of big data in biomedical
research taxes the ability of many researchers to release, locate, analyze, and
interact with these data and associated software due to the lack of tools,
accessibility, and training. In response to these new challenges in biomedical
research, and in response to the recommendations of the Data and Informatics
Working Group (DIWG) of the Advisory Committee to the National Institutes of
Health (NIH) Director (http://acd.od.nih.gov/diwg.htm),
NIH has launched the trans-NIH Big Data to Knowledge Initiative (https://datascience.nih.gov/bd2k).

Over the past several years, several not-for-profit data
science-related organizations have arisen to bring together interested parties
to address emerging issues in biomedical data science (e.g., data
accessibility, sharing, and interoperability; digital publishing). These groups
are defined by a mission focus on one or more areas of biomedical data science
and operational characteristics of transparency, open participation and bottom-up
priority setting and governance. In keeping with the highly participatory,
grass-roots nature of these organizations, much of their work is accomplished
through convening of various stakeholder groups. This occurs in many ways, from
large conferences and plenaries to seminars, webinars, workshops and
web-supported, regular interactions of working groups.

General FOA Objectives and Requirements

This FOA targets not-for-profit data science-related
organizations, whose work aligns with, and is complementary to, the overall mission
of BD2K. Specifically, this FOA solicits applications from organizations requesting
support for high quality and impactful conferences/meetings focused on emerging
issues in biomedical data science. A "conference" may be based on a
formal meeting where people assemble in person or other formats such as meeting
online via web conferencing and/or videoconferencing applications.

Conferences that would be appropriate for support under this
FOA may be in diverse areas of the field of biomedical data science, as long as
they are relevant to BD2K mission. Examples of such areas include, but are not
limited to, the following aspects:

Digital resource discovery, citation and access;

Data and metadata standards;

Ethical Legal and Social Implications (ELSI) of biomedical data
science;

Data management, transformation, and analysis tools; and

Permission to Submit Application. Support of conferences
under this FOA is contingent on the fiscal and programmatic interests and
priorities of the NIH BD2K Program. Therefore, the PD(s)/PI(s) of a conference cooperative
agreement application is required to obtain a permission-to-submit letter (for respective
contact, see Section VII. Agency Contacts.).

Applicants are urged to initiate contact well in advance of
the chosen application receipt date to discuss the proposed meetings and ensure
they address current BD2K programmatic priorities. This initial contact should
occur no later than 6 weeks before that due date. Please note that agreement to
accept an application does not guarantee funding.

The NIH website on NIH Support for Conferences
and Scientific Meetings centralizes information regarding grants and
cooperative agreements for scientific conferences. The Contacts
and Special Interests website includes contact information for the
participating ICs as well as information about each IC’s specific interests and
funding parameters. This website and related links are updated frequently, so
interested parties should check periodically for the most current information.

Applicants responding to this FOA may request support for a single
meeting or series of meetings. The proposed meeting(s) must address one or more
aspects identified in the NIH BD2K Mission Statement. Successful
applicants will work with NIH staff post-award to ensure that the meeting goals
are well aligned with the BD2K interests.

Appropriate Representation and Conference Environment.
A critical part of the application for NIH conference support is the
documentation of appropriate representation of women, racial/ethnic minorities,
persons with disabilities, and other individuals who have been traditionally
underrepresented in science in the planning and implementation of, and
participation in, the proposed conference. “Appropriate representation” means
representation based on the availability of these scientists from these groups
known to be working in a field of biomedical or behavioral research. If appropriate
representation is not apparent, no award will be issued until program staff
members are assured of concerted recruitment efforts.

Efficient Spending Requirements. The NIH
Policy on Promoting Efficient Spending: Use of Appropriated Funds for
Conferences and Meeting Space, Food, Promotional Items, and Printing and
Publications requires advance approvals prior to any obligation of funds
(i.e., issuance of a Notice of Grant Award). The approval process, which does
not begin until after an application has been peer reviewed, undergoes a
second-level review by an NIH Advisory Council and if selected for funding, can
take 2-3 months. To facilitate the approval process, each applicant
organization identified for funding will need to work closely with the NIH to
provide additional details regarding the funds requested. Applicants are
encouraged to consider this extended timeline in conference planning. For
applications requesting multiple years of support, a separate approval process
is needed each year. For conference grant and efficient spending guidance,
please click here.

Please visit the BD2K site Frequently Asked
Questions (FAQs) site (https://datascience.nih.gov/bd2k/faqs/u13#CommunityMtgs
) for answers to questions related to this announcement.

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement.
Substantial involvement means that, after award, NIH scientific or program
staff will assist, guide, coordinate, or participate in project activities. See
Section VI.2 for additional information about the substantial involvement for
this FOA.

Application Types Allowed

New

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

NIH intends to fund approximately 4-5 awards,
corresponding to $2,000,000 in total costs in fiscal year 2017. Since the
nature and scope of the proposed conferences/scientific meetings will vary
from application to application, it is anticipated that the size and duration
of each award could vary.

Award Budget

Application budget requests should reflect the actual
needs for the proposed meeting(s) but must not exceed $470,000 annually in
direct costs.

Award Project Period

The scope of the proposed conference(s)/scientific meeting(s)
should determine the project period. The maximum project period is three years.

NIH grants policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education
Institutions are always encouraged to apply for NIH support as Public or
Private Institutions of Higher Education:

Eligibility is restricted to data science related
organizations that are not-for-profit organizations with a mission focus on one
or more areas of biomedical data science, operational characteristics of open
participation, and bottom-up priority setting and governance, and who regularly
bring together interested parties to work on emerging issues in biomedical data
science (e.g., data sharing and interoperability, digital publishing).

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to
apply.
Foreign components, as defined in
the NIH Grants Policy Statement, are allowed.

Required
Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons. If the PD/PI is also the organizational Signing Official,
they must have two distinct eRA Commons accounts, one for each role. Obtaining
an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

PD(s)/PI(s) must have expertise in one or more areas of
biomedical data science and skills and experience needed for
promoting/facilitating open interactions among scientists, bottom-up priority
setting and governance, and ability to bring together interested parties to
work on emerging issues in biomedical data science (e.g., data sharing and
interoperability, digital publishing).

If multiple PDs/PIs are designated, at least the Contact
PD/PI must be from the application-submitting not-for-profit organization with
a mission relevant to biomedical data science.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct and proposes a
different meeting or meeting series.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an
Application Package

Buttons to access the online ASSIST system or to download
application forms are available in Part
1 of this FOA. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the Research Instructions for the SF424
(R&R) Application Guide, including Supplemental
Grant Application Instructions except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

All page limitations described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide
must be followed.

Descriptive
Title of Applicant’s Project: Enter the title of the scientific
conference.

Cover
Letter: Contacting NIH for information on eligibility is encouraged
and advance permission to submit an application is required. Advance permission
to submit an application should be requested early in the process and must be
requested no later than six weeks before the application due date. All
applicants must include the permission-to-submit letter from the BD2K
permission letter contact person (see Section
VII. Agency Contacts), who has agreed to accept assignment of the
application. Applications that do not include the permission-to-submit letter
will not be accepted for review. Note that advance permission to submit an
application does not guarantee funding. Please see Section I. Funding Opportunity
Description for further details.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide
must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide
must be followed.

R&R Budget

All instructions in the SF424 (R&R) Application Guide
must be followed. with the following additional instructions:

The person listed as Financial/Grants Management Contact in Section VII should be
consulted for guidance regarding any specific budget requirements. Enter the
direct costs requested. Facilities and Administrative (F&A) costs are not
allowed. Provide a narrative justification for each proposed personnel
position, including the role of the individual in the conference and the
proposed level of effort. Include information regarding efforts to obtain funding
for this conference from other sources.

Allowable
Costs include: Salary (in proportion to the time or effort spent
directly on the conference); rental of necessary equipment; travel and per diem
or subsistence allowances; supplies needed for conduct of the conference (only
if received for use during the budget period); conference services; publication
costs; funds to help defray registration costs for some select attendees (for
example, women, racial/ethnic minorities, persons with disabilities, other
individuals who have been traditionally underrepresented in science, graduate
students); speakers’ fees.

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide
must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Research
Strategy: Note that this section will be called “Conference
Plan” in the system-generated Table of Contents.

In the “Conference Plan” section of the application
(uploaded as the Research Strategy attachment), describe the organization and
the community(-ies) it represents. Identify the role of the PD(s)/PI(s) in the
organization. Describe the organization's mission, history and focus on biomedical
data science. Describe the organizational characteristics and prior activities
that support its community-based nature (e.g., open participation and broad
outreach to relevant stakeholders, bottom-up priority setting and governance).
Describe the alignment of the organization's mission with the broad objectives
of the NIH Big Data to Knowledge (BD2K) program.

Describe the objectives, specific program, and logistical
arrangements for the conference(s). Describe the format and list the agenda and
speakers, including the principal topics to be covered, problems to be
addressed, and developments or contributions the conference(s) might stimulate.
Provide a detailed justification for the conference(s), including the
scientific need, timeliness, and usefulness of the conference(s) to the
scientific community.

Describe the composition and role of the organizing
committee, and provide the names and credentials of key participants (i.e.
speakers, presenters, session moderators) in the conference, including the
basis for their selection and documentation of their agreement to participate.

Estimate the expected size and composition of the audience,
as well as the method of selection. Address plans to seek appropriately
balanced representation among invited participants and plans to encourage
attendance by women, minorities, and persons with disabilities.

Identify resources for child care and other types of family
care at the conference site to allow individuals with family care
responsibilities to attend.

Describe plans for publicizing the conference to all
interested participants and for publishing the proceedings (with the latter
plan not being required). Identify related conferences held on the subject
during the past 3 years and how the proposed conference is similar to and/or
different from these, and why it is still necessary and useful. If this is one
in a series of periodic conferences held by a permanent sponsoring
organization, briefly describe and evaluate the last conference in the series.

Applications requesting multiple years of support must
provide the following additional information for each future year requested, in
as much detail as possible:

Conference topic(s);

Tentative dates, locations, and participants; and

Contingency plans for future conferences dependent upon, for
example, the outcome of the first year’s conference or developments in the
field.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans as provided in the SF424 (R&R)
Application Guide, with the following modification:

All applications, regardless of the amount of direct costs
requested for any one year, should address how relevant resources (e.g.,
reports, white papers, draft standards) resulting from the conference will be
shared with the public.

Appendix:
Do not use the Appendix to circumvent page limits. Follow all
instructions for the Appendix as described in the SF424 (R&R) Application
Guide.

PHS Inclusion Enrollment Report

When conducting clinical research, follow all instructions
for completing PHS Inclusion Enrollment Report as described in the SF424
(R&R) Application Guide.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide
must be followed.

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO Commercial
and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the application
due date and time. If a Changed/Corrected application is submitted after the
deadline, the application will be considered late. Applications that miss the
due date and time are subjected to the NIH Policy on Late Application
Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission, contact the Application Submission Contacts in Section VII.

Important
reminders:

All PD(s)/PI(s) must include their eRA
Commons ID in the Credential fieldof the Senior/Key Person Profile
Component of the SF424(R&R) Application Package. Failure to register
in the Commons and to include a valid PD/PI Commons ID in the credential field
will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information
on registration requirements.

The applicant organization must ensure
that the DUNS number it provides on the application is the same number used in
the organization’s profile in the eRA Commons and for the System for Award Management.
Additional information may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review and responsiveness by components
of participating organizations, NIH. Applications that are incomplete, non-compliant
and/or nonresponsive will not be reviewed.

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the project to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does this conference address an important
problem? If the aims of the application are achieved, how will scientific
knowledge or clinical practice be advanced? What will be the effect of these
endeavors on the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?

Specific to this FOA: If
the aims of the application are achieved, how will the activities advance the
mission of the BD2K program? How well do the goals of the conference/scientific
meeting align with those of the BD2K program? To what extent will the meeting
enable cross fertilization with BD2K activities?

Investigator(s)

Is(are) the PD(s)/PI(s) well suited for
organizing and fulfilling the goals of this conference? Are the qualifications
and past performance of the PD(s)/PI(s) appropriate, and are they well suited
for their described roles in the conference? Are the key personnel and selected
speakers appropriate and well suited for their described roles in the
conference?

Specific to this FOA: How
appropriate are the PD(s)/PI(s) roles and involvement with the data
science-related organization for ensuring that the meeting will reflect the
goals and governance principles of that organization?

Innovation

Does the conference employ novel
approaches or methods to fulfill its purpose? Does the conference draw together
appropriate experts who may otherwise not have an opportunity to meet?

Approach

Are the format and agenda for the
conference appropriate for achieving the specified goals? Is the conference
timely for the subject matter? For applications designating multiple PDs/PIs,
is the Leadership Plan approach, including the designated roles and
responsibilities, governance and organizational structure consistent with and
justified by the topics of the conference and the expertise of each of the
PDs/PIs?

Specific to this FOA: How
strong are the plans for publicizing the conference to all interested
participants and/or for publishing the proceedings (if applicable)? How well
does the application identify related conferences held on the subject during
the past 3 years and justify the need for the proposed conference? How
appropriate are the proposed types of speakers for their described roles in the
conference/scientific meeting?

Environment

Is the conference site appropriate? Does
the applicant organization have the ability to contribute to the probability of
success? Do the proposed meetings, exhibits, interactions, etc., take advantage
of unique features of the environment or employ useful collaborative
arrangements? Is institutional support evident?

Specific to this FOA: How
well does the data science-related organization's mission and history support a
focus on biomedical data science? How well does the applicant organization
focus on community driven processes (e.g., open participation and broad
outreach to relevant stakeholders, bottom-up priority setting and governance)?
How does the organization's mission align with the broad objectives of the NIH
Big Data to Knowledge (BD2K) program?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Generally not applicable. Reviewers should
bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and
Children

Generally not applicable. Reviewers should
bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should
bring any concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should
bring any concerns to the attention of the Scientific Review Officer.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Provision of Family Care Facilities

Are the plans to inform attendees
about family care resources adequate?

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Generally not applicable. Reviewers
should bring any concerns to the attention of the Scientific Review Officer.

Reviewers will consider whether the
budget and the requested period of support are fully justified and reasonable
in relation to the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s) convened by the Center for
Scientific Review, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in
response to this FOA.

All applications will be assigned to NCI. Applications will
compete for available funds with all other recommended applications submitted
in response to this FOA. Following initial peer review, recommended applications
will receive a second level of review by the appropriate national Advisory
Council or Board. The following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement. All awards will be administered by NCI on
behalf of BD2K.

A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described
in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be
subject to terms and conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where nondiscriminatory
justifications establish that such criteria are appropriate with respect to the
health or safety of the subjects, the scientific study design, or the purpose
of the research.

In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal
Awardee Performance and Integrity Information System (FAPIIS) requirements.
FAPIIS requires Federal award making officials to review and consider
information about an applicant in the designated integrity and performance
system (currently FAPIIS) prior to making an award. An applicant, at its
option, may review information in the designated integrity and performance
systems accessible through FAPIIS and comment on any information about itself
that a Federal agency previously entered and is currently in FAPIIS. The
Federal awarding agency will consider any comments by the applicant, in
addition to other information in FAPIIS, in making a judgement about the
applicant’s integrity, business ethics, and record of performance under Federal
awards when completing the review of risk posed by applicants as described in
45 CFR Part 75.205 “Federal awarding agency review of risk posed by
applicants.” This provision will apply to all NIH grants and cooperative
agreements except fellowships.

For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is identified
in Section VII under Agency Contacts of this FOA. HHS provides general guidance
to recipients of FFA on meeting their legal obligation to take reasonable steps
to provide meaningful access to their programs by persons with limited English
proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and http://www.hhs.gov/ocr/civilrights/understanding/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other HHS,
PHS, and NIH grant administration policies.

The administrative and funding instrument used for this
program will be the cooperative agreement, an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial NIH
programmatic involvement with the awardees is anticipated during the
performance of the activities.

Under the cooperative agreement, the NIH purpose is to
support and stimulate the recipients' activities by involvement in and
otherwise working jointly with the award recipients in a partnership role; it
is not to assume direction, prime responsibility, or a dominant role in the
activities. Consistent with this concept, the dominant role and prime
responsibility resides with the awardees for the project as a whole, although
specific tasks and activities may be shared among the awardees and the NIH as
defined below.

The PD(s)/PI(s) will
have the primary responsibility for:

Defining objectives of the conference and approaches to its
development;

Awardees will retain the primary rights to information and
other resources developed under these awards, subject to Government rights of
access consistent with current DHHS, PHS, and NIH policies.

Awardees are responsible for identifying specific milestones
for conferences that will be supported during the project period, when
multi-year conferences are supported.

NIH
staff will have substantial programmatic involvement that is above and beyond
the normal stewardship role in awards, as described below:

The NIH Program staff members from respective Institutes/Centers
will be assigned to awards resulting from this FOA as "Project
Scientists". These Project Scientists will have substantial scientific and
programmatic involvement during the conduct of this activity through technical
assistance, advice and coordination that is above and beyond the normal
stewardship role in awards.

The Project Scientists will be expected to assist the
awardees in various aspects relevant to the award, such as:

Serving on Working Group of the U13 award BD2K Program;

Serving as liaisons, as needed, to additional expertise,
resources, etc., that might be needed;

Assisting the awardees in various scientific and organizational
aspects of the conference as appropriate:

Helping
optimize the content of the meeting and planning the agenda;

Suggesting
potential speakers;

Participating
in the assessment/acceptance of submitted conference presentations; and/or

Assisting
the awardees, conference organizers, invited speakers, and conference attendees
in other ways as needed for the goals of the initiative.

Note: Project Scientists will not serve as invited speakers
at the conferences to be supported under this FOA.

Additionally, an NIH Program Official will be responsible
for the normal scientific and programmatic stewardship of the U13 award. The
Program Official will be named in the award notice.

Areas
of Joint Responsibility include:

The PDs/PIs of the U13 awards under this FOA will form,
together with the NIH Project Scientists involved, a Working Group for the
program of "BD2K Support for Meetings of Data Science Related
Organizations". Other related NIH-BD2K staff members may also participate
in this group as appropriate. The NIH Project Scientist(s) will initiate the
formation of the Working Group and will facilitate its activities.

The primary roles of the Working Group will be to:

Serve as an interface between the individual U13 awardees funded
under this FOA and appropriate NIH (and, more specifically, BD2K) staff,
programs, and resources;

Discuss policy recommendations for areas applicable to all
conferences supported (e.g., regarding guidelines for publication of conference
materials); and

Harmonize other activities relevant to all individual projects
(conferences) collectively.

The meetings of the Working Group will take place as needed
(in person, virtually, or by teleconference).

Dispute
Resolution:

Any disagreements that may arise in scientific or
programmatic matters (within the scope of the award) between award recipients
and the NIH may be brought to arbitration. An Arbitration Panel composed of
three members will be convened. It will have three members: a designee of the Coordinating
Group chosen without NIH staff voting, one NIH designee, and a third designee
with expertise in the relevant area who is chosen by the other two; in the case
of individual disagreement, the first member may be chosen by the individual
awardee. This special arbitration procedure in no way affects the awardee's
right to appeal an adverse action that is otherwise appealable in accordance
with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part
16.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH
Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation under
Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value
greater than $10,000,000 for any period of time during the period of
performance of a Federal award, must report and maintain the currency of
information reported in the System for Award Management (SAM) about civil,
criminal, and administrative proceedings in connection with the award or
performance of a Federal award that reached final disposition within the most
recent five-year period. The recipient must also make semiannual
disclosures regarding such proceedings. Proceedings information will be
made publicly available in the designated integrity and performance system
(currently FAPIIS). This is a statutory requirement under section 872 of
Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010
of Public Law 111-212, all information posted in the designated integrity and
performance system on or after April 15, 2011, except past performance reviews
required for Federal procurement contracts, will be publicly available. Full
reporting requirements and procedures are found in Appendix XII to 45 CFR Part
75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.